Mechanical Bowel Preparation With or Without Oral Antibiotics in Left Sided Colorectal Cancer Surgery

NCT07429760 | Enrolling By Invitation DMC

• 1 other identifier: IRB 25-28
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, Investigator will compare mechanical bowel preparation with or without oral antibiotics in Left sided colorectal cancer patients undergoing elective surgery.

Conditions

Colorectal Cancer

Keywords

Colorectal Cancer; Oral Antibiotics; Mechanical bowel preparation

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infection (SSI)

  Any SSI and the type of SSI (superficial, deep incisional, and organ space) within 30 days of the index procedure based on the Centers for Disease Control and Prevention and National Nosocomial Infection Society criteria

  30 days

Secondary Outcomes (1)

• anastomotic leak

  30 days

Study Arms (2)

Mechanical bowel preparation with oral antibiotics

EXPERIMENTAL

Mechanical bowel preparation arm with oral antibiotics Orally administered preparation of polyethylene glycol 2 days before surgery+ three doses of rifaximin 400mg at 7am, 3pm and 11pm the day before surgery and a single dose of metronidazole 500mg 11pm the day before surgery.

Drug: Rifampicin (R)

Mechanical bowel preparation without oral antibiotics

NO INTERVENTION

Mechanical bowel preparation alone Orally administered preparation of polyethylene glycol 2 days before surgery

Interventions

Rifampicin (R) DRUG

Orally administered preparation of polyethylene glycol 2 days before surgery+ three doses of rifaximin 400mg at 7am, 3pm and 11pm the day before surgery and a single dose of metronidazole 500mg 11pm the day before surgery.

Also known as: Metronidazole

Mechanical bowel preparation with oral antibiotics

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients
• Diagnosed cases of left sided (distal to splenic flexure) colorectal cancer undergoing elective curative sphincter preserving surgery.
• No contraindication for preoperative administration of oral antibiotics and mechanical bowel preparation.

You may not qualify if:

• Emergency surgery
• Palliative surgery
• Unwilling to participate in a trial

Sponsors & Collaborators

• Shaukat Khanum Memorial Cancer Hospital & Research Centre: lead

Study Sites (1)

Shaukat Khanam Memorial Cancer Hospital & Research Centre Lahore

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Rifampin; Metronidazole

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study is double blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: February 24, 2026
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

PA (1)